News & Research

Related Q&A

PROCARDIA XL SUMMARY

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. PROCARDIA XL® Extended Release Tablet is similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an "active" layer containing the drug, and a "push" layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and "pushes" against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer.

PROCARDIA XL is indicated for the following:

I. Vasospastic Angina

PROCARDIA XL is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. PROCARDIA XL may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.

II. Chronic Stable Angina (Classical Effort-Associated Angina)

PROCARDIA XL is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.

In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete.

Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.)

III. Hypertension

PROCARDIA XL is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

This study was designed to investigate effects of Adalat GITS on hemodialytic blood
pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma
concentrations. For the purpose of investigating the influence of hemodialysis on the drug
plasma concentration as well as its efficacy, it should be necessary to assign the subjects
with the Adalat monotherapy. Since most patients in the hemodialysis center will be those
who need and already receive combination therapy, it would be practical to start Adalat
60mg/day monotherapy to remain similar antihypertensive effect when discontinuing the
previous treatment in this study population to be screened and enrolled. And taking into
the consideration of clinical practice, few patients undergoing hemodialysis could be well
controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and
safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the
drug plasma concentration without any other possible drug interaction. The agents are given
orally once a day at 08: 00h and patients are followed for at least 4 weeks. After that,the
patients whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood
pressure would be enrolled for further ABPM assessment and plasma concentration evaluation.

Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension [Recruiting]
This will be a multi-center, prospective, randomized, open-label, parallel design, two arm
comparator trial. In the proposed study, the investigators will compare low-dose combination
therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan
with respect to their blood pressure-decreasing effects in patients with essential
hypertension. The study consists of a screening visit, followed by randomization and
administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or
Valsartan 160 mg for 12 weeks of treatment. The primary efficacy parameters will be mean SBP
and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.

ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are

currently approved for use in patients with essential hypertension alone or together with
other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS
and candesartan used together in the treatment of essential hypertension has not been
established yet. In this study patients will be treated with various doses of nifedipine
GITS and/or candesartan or placebo. These different regimes will be administered once a day
and will be assessed based on their blood pressure lowering effects (mean sitting diastolic
blood pressure) in subjects with mild to moderate essential hypertension.